Scancell Share Discussion Threads

[bermudashorts] 13/8/2017 18:12

Smiler,

Agree -

[bermudashorts] 13/8/2017 18:11

Chelsea,

Are you trolling this board with negative posts? lol

[wanderer1210_0] 13/8/2017 18:11

On or Off label matters not one jot. What does matter is how Scancell get to that stage. With their past performances of cash calls all it can lead to is dilution at a significant reduction to current SP

[bermudashorts] 13/8/2017 18:10

Inanaco

Honestly, please read what I actually post. Whether or not it could be prescribed off label has never been in question. It's whether doctors actually would - see my 10336. I also think we need to be careful about raising expectations that approval in combination could lead to sales in the adjuvant setting. We disagree on that. That's absolutely fine and like most things we disagree on, I really hope that I'm wrong and you're right.

[chelsea34] 13/8/2017 18:05

On saying that, as i felt last Monday we did see some half decent buying at 10.50 last week, only for another tranche of selling to keep the downward pressure on and again lead to periods where selling was reduced to 100 shares as the week before. Just hoping this tranche doesn"t have the legs that the Helium one had. Evidence too that PIs are not jumping in at 10.50, as I have said confidence is low, promises of inflection breaking news have not transpired, PIs are prepared to pay more according to news. Another interesting week ahead.

[chelsea34] 13/8/2017 18:05

On saying that, as i felt last Monday we did see some half decent buying at 10.50 last week, only for another tranche of selling to keep the downward pressure on and again lead to periods where selling was reduced to 100 shares as the week before. Just hoping this tranche doesn"t have the legs that the Helium one had. Evidence too that PIs are not jumping in at 10.50, as I have said confidence is low, promises of inflection breaking news have not transpired, PIs are prepared to pay more according to news. Another interesting week ahead.

[inanaco] 13/8/2017 17:50

thanks boom .... my original post


nanaco13 Aug '17 - 12:32 - 10317 of 10360 0 0 Edit
Now lets say Scancell achieved approval for the Combo ... not sure exactly how this would work, but the data set for Mono SCib1 could allow it to be used in the adjuvant setting

Why might an approved drug be used for an unapproved use?

From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.
You may be asking yourself why your healthcare provider would want to prescribe a drug to treat a disease or medical condition that the drug is not approved for. One reason is that there might not be an approved drug to treat your disease or medical condition. Another is that you may have tried all approved treatments without seeing any benefits. In situations like these, you and your healthcare provider may talk about using an approved drug for an unapproved use to treat your disease or medical condition.

[bermudashorts] 13/8/2017 17:47

Yes of course it could be prescribed off label - ????

lol we have come full circle. Catch you later.

[inanaco] 13/8/2017 17:41

thanks boom

if its two treatments then .... scib1 would require an approved license for use as a drug ... so it could be prescribed off label


c7 posted the same post twice ... i am not engaging him at all only the highlighted text

in Scancells case it goes way deeper just refining his post to remove any confusion as to what is combined ...

[bermudashorts] 13/8/2017 17:31

"I just hope you appreciate they are two different treatments that function in completely different ways which produce a combined synergy effect"

Thanks for the heads up but I had picked that up from my research. I don't know why you have such an issue with the wording 'combined with' or why you have pulled Chelsea up on it - Scancell use it all the time. Nobody has ever suggested that it's combined with the PD-1 before administration.

[chelsea34] 13/8/2017 17:30

On saying that, as i felt last Monday we did see some half decent buying at 10.50 last week, only for another tranche of selling to keep the downward pressure on and again lead to periods where selling was reduced to 100 shares as the week before. Just hoping this tranche doesn"t have the legs that the Helium one had. Evidence too that PIs are not jumping in at 10.50, as I have said confidence is low, promises of inflection breaking news have not transpired, PIs are prepared to pay more according to news. Another interesting week ahead.

[inanaco] 13/8/2017 17:13

C7

""for use when combined with Keytruda""

they don't combine the drugs .....

[chelsea34] 13/8/2017 17:10

Bermuda, therein lies the frustration of all LTHs. I also don"t blame Scancell for the delay we have endured awaiting manufacture of the new vaccine. Can"t imagine any small biotech on the AIM market having £1m of shareholders money tied up in new vaccine ""in the event of"", as we have seen. The need to get SCIB1 into the trial with Keytruda and gain approval ""for use when combined with Keytruda"" will only bring in the sort of investment we need to prove up Immunobody further as a mono therapy for treatment in early detection cancers long before stage 4 diagnosis.

Nobody knows what will be declared by the BOD by the AGM, and further down the road. Again at just over 10p on the ask ,risk/reward makes this a very interesting play.

[inanaco] 13/8/2017 17:10

Scancell has it spot on .... its a combination treatment, its a combination trial

what its not is a combined drug to form a single drug delivery

[inanaco] 13/8/2017 17:07

... happy to leave it anyway i do have things to do ...

I just hope you appreciate they are two different treatments that function in completely different ways which produce a combined synergy effect

[bermudashorts] 13/8/2017 16:55

Inan - I gave you the link and the definition the FDA use. If you think they're wrong then contact them and while you're at it ask Scancell to stop using the terms combination trial and combination treatment.

[bermudashorts] 13/8/2017 16:52

Inanco - I think we have real problems with written communication. Probably both at fault but we seem to take completely different meanings from the same words.

Let's just agree on that point.

[inanaco] 13/8/2017 16:51

you posted

When the FDA approve a drug, they are very specific about what it is being approved for - labelled indications. In SCIB1's case it's likely to be something along the lines of for use when combined with Keytruda for patients with non-resectable melanoma etc. etc.

If a doctor uses it in any other circumstances then he will be using it off label.

It will be supplied in the same way any other drug is supplied.


just to remind you they cannot combine the drugs prior to delivery to the patient

they are two drugs given at different times which combine only at the tumor site.

[chelsea34] 13/8/2017 16:50

Bermuda, therein lies the frustration of all LTHs. I also don"t blame Scancell for the delay we have endured awaiting manufacture of the new vaccine. Can"t imagine any small biotech on the AIM market having £1m of shareholders money tied up in new vaccine ""in the event of"", as we have seen. The need to get SCIB1 into the trial with Keytruda and gain approval ""for use when combined with Keytruda"" will only bring in the sort of investment we need to prove up Immunobody further as a mono therapy for treatment in early detection cancers long before stage 4 diagnosis.

Nobody knows what will be declared by the BOD by the AGM, and further down the road. Again at just over 10p on the ask ,risk/reward makes this a very interesting play.

[inanaco] 13/8/2017 16:47

Scib1 is a standalone treatment when combined with PD1 as a stand alone treatment there synergy at the tumor site is established

[bermudashorts] 13/8/2017 16:40

what?????

You were saying that approval as a combination treatment will lead to off label prescribing as an adjuvant treatment. No it won't.

You also seem to be trying to suggest that it isn't a combination treatment and that approval would be as a standalone treatment - it is and wouldn't.

Think we should just leave it - we are clogging the bb up and am sure we both have much better things to do with our Sunday afternoon.

[inanaco] 13/8/2017 16:38

I am not wishing anything boom ..... just pointing out that its two treatments of two drugs to gain synergy thus to get approved SCIB1 has to be given a license

[bermudashorts] 13/8/2017 16:34

Inanaco -

The fact that Keith Flaherty uses the word 'addition' does not mean that it's not a combination therapy - no matter how much we wish it did. It's even described as a combination trial! Look just check on FDA website as to definition of combination product. The following excerpts make it absolutely clear :-

What is a combination product?

A combination product is a product composed of any combination of a drug and a device

Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.

hxxps://www.fda.gov/combinationproducts/aboutcombinationproducts/ucm101496.htm

[inanaco] 13/8/2017 16:31

nanaco13 Aug '17 - 12:32 - 10317 of 10343 0 0 Edit
Now lets say Scancell achieved approval for the Combo ... not sure exactly how this would work, but the data set for Mono SCib1 could allow it to be used in the adjuvant setting

Why might an approved drug be used for an unapproved use?

From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.
You may be asking yourself why your healthcare provider would want to prescribe a drug to treat a disease or medical condition that the drug is not approved for. One reason is that there might not be an approved drug to treat your disease or medical condition. Another is that you may have tried all approved treatments without seeing any benefits. In situations like these, you and your healthcare provider may talk about using an approved drug for an unapproved use to treat your disease or medical condition.

[inanaco] 13/8/2017 16:28

Boom

which is exactly the point i made in the first place ....